Evaluation of the Product Properties of Individualized 3D-compression Garments to Treat Scars
1 other identifier
interventional
10
1 country
1
Brief Summary
Burn scars are treated with compression garments. These are produced based on manual measure data. The aim of this study is to evaluate correct fitting, wearing comfort, suitability for daily use and scar properties after using garments produced on base of measuring data from scanning in comparison to manual measured data.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2018
CompletedStudy Start
First participant enrolled
September 6, 2018
CompletedFirst Posted
Study publicly available on registry
September 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedDecember 3, 2019
December 1, 2019
2 months
August 31, 2018
December 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Fitting of the garment (on a numeric rating scale 0-10)
Numeric rating scale from 0 (minimum) to 10 (maximum) judged by the patient: 0 means perfect fitting, 10 means no fitting). Higher values represent a worse outcome.
3 months
Secondary Outcomes (2)
Comfort of the garment (on a numeric rating scale 0-10)
3 months
Daily use of the garment (on a numeric rating scale 0-10)
3 months
Study Arms (2)
Garment based on manual measurement
ACTIVE COMPARATORGarment based on manual measurement is used on burn scar
Garment based on scan measurement
EXPERIMENTALGarment based on scan measurement is used on burn scar
Interventions
Garment based on manual measurement
Eligibility Criteria
You may qualify if:
- Burn scars on an arm after IIa-III. burn (1-30% surface area)
- Indication for burn garments
- Experience in using burn garments
You may not qualify if:
- Consume of pain killer
- Medication with cortisone or immun suppressive therapy
- Psychiatric disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- The patient receives two different burn garments and does not know which one was produced based on the scan data and which one on the manual measuring.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 31, 2018
First Posted
September 10, 2018
Study Start
September 6, 2018
Primary Completion
November 9, 2018
Study Completion
December 1, 2019
Last Updated
December 3, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share